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Date Printed: October 21, 2017: 11:32 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-44

Original Effective Date: 01/01/12

Reviewed: 09/13/17

Revised: 10/15/17

Subject: Erlotinib (Tarceva®) Tablets

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Erlotinib (Tarceva®) is an oral, selective epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). EGFR is expressed, overexpressed or dysregulated in a variety of cancers including breast cancer, non-small cell lung cancer (NSCLC), and ovarian cancer. Erlotinib was initially approved by the US Food and Drug Administration for the treatment of NSCLC in 2004. In 2005, the approval was expanded to include treatment of pancreatic cancer. Current National Comprehensive Cancer Network guidelines support the use of erlotinib in the treatment of NSCLC, pancreatic, and chordoma.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of erlotinib (Tarceva®) meets the definition of medical necessity for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Bone Cancer-Chordoma

a. Member has recurrent disease

b. Erlotinib is used as monotherapy

c. Dose does not exceed 150 mg daily (dosage will be achieved using the fewest number of tablets per day) with the following exceptions:

i. Dose does not exceed 450 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is receiving a concomitant strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s Wort)

ii. Dose does not exceed 300 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is a current cigarette smoker

2. Non-Small Cell Lung Cancer AND known sensitizing epidermal growth factor receptor mutation

a. Member has a documented epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation – laboratory documentation must be provided

b. Member has recurrent or metastatic disease

c. Erlotinib will be used as monotherapy

d. Dose does not exceed 150 mg daily (dosage will be achieved using the fewest number of tablets per day) with the following exceptions:

i. Dose does not exceed 450 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is receiving a concomitant strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s Wort)

ii. Dose does not exceed 300 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is a current cigarette smoker

3. Pancreatic Adenocarcinoma

a. Member has locally advanced, unresectable, or metastatic disease

b. Erlotinib will be used in combination with gemcitabine (Gemzar®)

c. Dose does not exceed 100 mg daily (dosage will be achieved using the fewest number of tablets per day) with the following exceptions:

i. Dose does not exceed 450 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is receiving a concomitant strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s Wort)

ii. Dose does not exceed 300 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is a current cigarette smoker

4. Kidney Cancer

a. Member meets one of the following:

i. Member’s disease is relapsed

ii. Member’s disease is stage IV AND medically or surgically unresectable

b. Use is in disease with non-clear cell histology

c. Erlotinib will be used as first-line therapy

d. Erlotinib will be used as monotherapy

e. Dose does not exceed 150 mg daily (dosage will be achieved using the fewest number of tablets per day) with the following exceptions:

i. Dose does not exceed 450 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is receiving a concomitant strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s Wort)

ii. Dose does not exceed 300 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is a current cigarette smoker

Approval duration: 6 months

Continuation of erlotinib (Tarceva) meets the definition of medical necessity when ALL of the following criteria are met:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years for treatment of bone cancer, NSCLC with an EGFR exon 19 deletion or exon 21 substitution, pancreatic adenocarcinoma, or kidney cancer, OR the member currently meets all indication-specific initiation criteria.

2. Member has a known EGFR-sensitizing mutation (NSCLC) OR member’s disease has not progressed during treatment with erlotinib

3. Dose does not exceed 150 mg daily (dosage will be achieved using the fewest number of tablets per day) with the following exceptions:

a. Dose does not exceed 450 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is receiving a concomitant strong CYP3A4 inducer (e.g., phenytoin, rifampin, carbamazepine, St. John’s Wort)

b. Dose does not exceed 300 mg daily (dosage will be achieved using the fewest number of tablets per day) AND member is a current cigarette smoker

Approval duration: 1 year

Erlotinib meets the definition of medical necessity when used to treat the following designated Orphan Drug indication when the dose does not exceed the maximum FDA-approved dose:

1. Malignant gliomas

Approval duration: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved:

NSCLC: 150 mg orally, on an empty stomach, once daily

Pancreatic cancer: 100 mg orally, on an empty stomach, once daily

Dose Adjustments:

Recommendations for dose modifications due to adverse reactions are provided in FDA-approved Prescribing Information

Strong CYP3A4 inhibitors: Reduce dose by 50 mg

CYP3A4 inducers: Increase dose by 50 mg increments at two week intervals to a maximum of 450 mg as tolerated

Concurrent cigarette smoking: Increase dose by 50 mg increments at two week intervals to a maximum of 300 mg

Drug Availability:

Tablets: 25 mg, 100 mg, and 150 mg

PRECAUTIONS:

• ILD: withhold erlotinib for acute onset of new or progressive unexplained pulmonary symptoms, such as dyspnea, cough and fever. Discontinue erlotinib if ILD is diagnosed

• Renal Failure: monitor renal function and electrolytes, particularly in persons at risk of dehydration. Withhold erlotinib for severe renal toxicity.

• Hepatotoxicity: hepatotoxicity with or without hepatic impairment including hepatic failure and hepatorenal syndrome. Monitor liver function tests and withhold or discontinue erlotinib for severe or worsening liver tests.

• GI perforations: discontinue erlotinib

• Bullous and exfoliative skin disorders: discontinue erlotinib

• Myocardial infarction/ischemia: risk of MI is increased in persons with pancreatic cancer

• Cerebrovascular accident (CVA): the risk of CVA is increased in persons with pancreatic cancer.

• Microangiopathic hemolytic anemia (MAHA): the risk of MAHA is increased in persons with pancreatic cancer.

• Ocular disorders: discontinue erlotinib for corneal perforation, ulceration or persistent severe keratitis.

• Hemorrhage in persons taking warfarin: regularly monitor INR in persons taking warfarin or other coumarin-derivative anticoagulants

• Embryo-fetal toxicity: can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use highly effective contraception.

BILLING/CODING INFORMATION:

HCPCS Coding

C9399

Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

J8999

Prescription drug, oral, chemotherapeutic, NOS

ICD-10 Diagnosis Codes That Support Medical Necessity

C25.0 – C25.3

Malignant neoplasm of pancreas

C25.7 – C25.9

Malignant neoplasm of pancreas

C33

Malignant neoplasm of trachea

C34.00 – C34.32

Malignant neoplasm of bronchus or lung

C34.80 – C34.92

Malignant neoplasm of bronchus or lung

C64.1-C64.9

Malignant neoplasm of kidney, except renal pelvis

C65.1-C65.9

Malignant neoplasm of renal pelvis

C72.0

Malignant neoplasm of spinal cord

C72.1

Malignant neoplasm of cauda equina

C79.31

Secondary malignant neoplasm of brain

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Brachytherapy-Oncologic Applications, 04-77260-20

Denosumab (Prolia™; Xgeva™) Injection, 09-J1000-25

Docetaxel (Taxotere®) IV, 09-J0000-95

Gemcitabine (Gemzar®), 09-J0000-96

Gonadotropin Releasing Hormone Analogs and Antagonists, 09-J0000-48

Intensity-Modulated Radiation Therapy (IMRT), 04-77260-22

Irinotecan HCl (Camptosar®) IV, 09-J0000-99

Magnetic Resonance Angiography (MRA), 04-70540-08

Oxaliplatin (Eloxatin®) IV, 09-J1000-00

Pemetrexed Disodium (Alimta®) IV, 09-J1000-01

Positron Emission Tomography (PET Scans) Oncologic Applications, 04-78000-17

Stereotactic Body Radiotherapy, 02-77371-02

Topotecan HCl (Hycamtin®) IV, 09-J1000-02

Vinorelbine Tartrate (Navelbine®) IV, 09-J1000-03

Zoledronic Acid IV (Reclast®; Zometa®), 09-J0000-72

OTHER:

TABLE 1:

ECOG PERFORMANCE STATUS*

Grade

ECOG

0

Fully active, able to carry on all pre-disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2

Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair

5

Dead

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 8/28/17]. Available from: http://www.clinicalpharmacology.com/.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 8/28/17]. Available from: http://clinicaltrials.gov/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 8/28/17]. Available from: http://www.thomsonhc.com/.
  4. Ingenex, HCPCS Level II, Expert 2013.
  5. Ingenex, ICD-9-CM for Physicians – Volumes 1 & 2, Expert 2013.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Bone cancer, v. 1.2018 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  8. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Non-small cell lung cancer, v. 8.2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  9. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Pancreatic cancer, v. 2.2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  10. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Kidney cancer, v. 2.2017 [cited 8/28/17]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  11. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 8/28/17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 09/13/17.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

11/15/12

Review and revision to guideline, consisting of updating position statement, added contraindication section, updated program exceptions, added ECOG PS table, and updated references.

09/15/13

Revision to guideline; consisting of administrative action to add treatment of chordoma to position statement and update coding.

11/15/13

Review and revision to guideline; consisting of revising description section, dosage/administration, and precautions section, updating references.

12/15/14

Review and revision to guideline; consisting of position statement, coding, references

12/15/15

Review and revision to guideline, consisting of updating position statement, decription, references.

09/15/16

Review and revision to guideline, consisting of updating position statement, coding, references.

12/15/16

Revision to guideline; consisting of updating position statement and references.

10/15/17

Review and revision to guideline, consisting of updating position statement, coding, references.

Date Printed: October 21, 2017: 11:32 AM